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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K151704
Device Name Diplomat® Spinal System
Applicant
SIGNUS Medizintechnik GmbH
Industriestr. 2
Alzenau,  DE 63755
Applicant Contact Jochim Schneider
Correspondent
Empirical Testing Corp.
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Kenneth C Maxwell
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received06/24/2015
Decision Date 04/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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